Endoscopic sleeve gastroplasty (ESG) is safe and effective way for the treatment obesity and obesity-related comorbidities such as diabetes, high blood pressure and fatty liver, according to a study by NewYork-Presbyterian and Weill Cornell Medicine researchers. The paper, ‘Endoscopic Sleeve Gastroplasty Significantly Reduces Body Mass Index and Metabolic Complications in Obese Patients, was published in the journal of Clinical Gastroenterology and Hepatology.

“Obesity is a significant health concern that affects millions of people across the country, but until now there hasn’t been an effective minimally invasive treatment we could offer patients,” said Dr Reem Sharaiha, director of bariatric endoscopy and associate director of the Pancreas Program at NewYork-Presbyterian/Weill Cornell Medical Center and an assistant professor of medicine at Weill Cornell Medicine, and a consultant for Apollo Endosurgery. “With ESG, we’re giving patients who are not eligible for surgery, or deemed to be too high risk for surgery a new option for their care.”

ESG is an incisionless, minimally invasive bariatric procedure performed via an endoscopic rather than surgical approach. The goal of ESG is to reduce the length and width of the stomach to facilitate weight loss using a transmural tissue apposition technique by using a full-thickness endoscopic suturing system (OverStitch, Apollo EndoSystems).

The study followed 91 patients who underwent ESG from August 2013 through March 2016. All patients were clinically obese with a BMI>30 and had failed non-invasive weight-loss measures, or had a BMI>40 and were not considered as surgical candidates or had refused surgery.

The procedure is contraindicated in patients with gastric lesions, neoplastic findings, or family history of gastric cancer. In addition to a pre-procedural consultation with the gastroenterologist, patients were also seen by an endocrinologist, a nutritionist, and a psychologist to provide a multidisciplinary approach.

The primary outcome was total body weight loss (TBWL) at six, 12, and 24 months. Clinical success was defined as TBWL of at least 15%. Secondary outcomes included the impact of ESG on metabolic comorbidities, including systolic blood pressure (SBP), diabetes (measured by HbA1c), hyperlipidaemia (measured by LDL and serum TG), steatohepatitis (measured by alanine aminotranferase [ALT]), and safety. The authors also attempted to define a learning curve for ESG.

Outcomes

Ninety-one patients underwent ESG during the study period. All patients had at least six months of follow-up, but follow-up data was available on 73 patients (80%). At 12 months 69 patients were eligible, but follow-up data was available on 53 patients (76%). Twelve patients had 24 months of follow-up, but follow-up data was available on eight patients (66%). The mean ± SD age was 43.66±11.26 years, mean BMI was 38.6±7.0 kg/m2 (range, 30.0–68.0), 68% were female, and 34% were white.

Eighteen patients (19.8%) had type 2 diabetes mellitus at baseline, of whom 13 patients (14.3%) were on medications. An additional 15 patients (16.5%) were prediabetic at the time of the pre-procedure consultation. Eighteen patients (19.8%) were diagnosed with hypertension and were on antihypertensive medications, and 13 patients (14.3%) had dyslipidaemia and were taking cholesterol lowering medications.

All patients underwent successful ESG with general anaesthesia and the mean procedure time was 98.3±39.3 minutes. The mean procedure time for the first 35 cases was 144.9 ± 39.4 minutes, compared with the mean procedure time of the subsequent cases of 74.32 ± 18.7 minutes (p<0.001). The ESG procedure required a median of six sutures for the first layer and three sutures for the second layer. The mean size of the stomach, defined as measurement from the pylorus to the GE junction, before ESG was 34.8cm and decreased to 20.4cm after ESG (p<0.001). The first 11 patients were admitted to the hospital after ESG for observation, and their mean length of stay was 2.1 days. All subsequent patients (n=80) were discharged home the same day.

Weight loss

The mean %TBWL was 14.4% at six months, increased to 17.6% at 12 months and 20.9% at 24 months (Figure 1). The decrease in weight at each time point compared with baseline was statistically significant (all p<0.001). The BMI decreased from a mean of 40.7 to 32 at 12 months (p< 0.001). Seventy percent of patients at 12-month follow-up achieved clinical success as defined by greater than 15% TBWL. In addition, waist circumference significantly decreased from 119.7±14.1cm to 92.8±5.9cm (p=0.001) at 12 months.

There was a statistically significant change in HbA1c between baseline and at 12 months after ESG in the overall cohort (mean ± SD, 6.1% ± 1.1% vs 5.5% ± 0.48%, respectively; p=0.0.05). In patients with diabetes or pre-diabetes, there was a significant reduction in HgA1c (mean ± SD, 6.6% ± 1.2% vs 5.6% ± 0.51%, respectively; p=0.02). Furthermore, five patients in total were able to stop insulin, and two patients stopped all medications.

In univariate analysis, younger age was significantly associated with weight loss at 12 months. In addition, there was a statistically significant difference in achieving %TBWL before and after the 34 cases (p=0.031), even after adjusting for initial BMI and gender. There was no statistically significant effect of the suture number (in both the first and second layers), change in stomach size, total number of sutures, and diabetic status on %TBWL at 12 months (p>0.05).

There was one (1.1%) serious adverse event that occurred with a patient who developed a peri-gastric leak, which was managed non-operatively with placement of a percutaneous drain. The leak resolved on subsequent imaging without any additional intervention.

“ESG has evolved into a same day, outpatient endoscopic procedure with a significant impact on weight loss and a low rate of adverse events,” the authors conclude. “This study demonstrates that ESG can reduce measures of obesity-associated medical comorbidities in addition to successful weight loss. Although long-term data are still needed, ESG has established its foothold in the armamentarium of bariatric therapy.”

A randomised control study which will compare ESG to diet and exercise has been approved and is now recruiting patients.